Senior Associate Regulatory Affairs

### HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

### Senior Associate Regulatory Affairs

#### Live
**What you will do**

Let’s do this. Let’s change the world. In this vital role, you will assist the US Regulatory Leads and the Global Regulatory Team (GRT) in the Regulatory Affairs organization.

– Coordinate and execute US regulatory submissions with the US Regulatory Lead in compliance with corporate standards and local regulatory requirements.
– Manage and execute the preparation, delivery, and electronic archiving of documentation for inclusion in US regulatory submissions.
– Assist the Global Regulatory Lead to manage GRT interactions.

**The responsibilities of the Regulatory Affairs Senior Associate position are:**

– Assist US Regulatory Lead to support regional regulatory activities (e.g., IND submissions and agency meetings).
– Provide and maintain CTA/MA documentation support (e.g., initial filings, amendments, and periodic reports) in collaboration with the Regional Regulatory Lead.
– Create and maintain product regulatory history documents through Amgen systems and appropriately archive all regulatory documents and agency communications.
– Review the regional component of the Global Regulatory Plan and provide input to operational deliverables.
– Collaborate with CROs/partners to support site initiation.
– Coordinate collection of functional documents in support of regulatory filings.
– Participate in GRT to support execution of regulatory strategy.
– Coordinate QC of regulatory documentation (e.g., briefing materials).
– Provide primary authorship to routine regulatory correspondence (e.g., annual reports, investigator packages).
– Prepare regulatory packages and cross-reference letters to support investigator-initiated studies.
– Complete regulatory forms to support agency communications.
– Provide regulatory support through cross-functional interactions in work package teams (e.g., commercial and evidence generation teams).
– Support process improvement initiatives, standards development, and metrics.
– Assist in template development and maintenance.
– Respond to specific requests from and communicate relevant issues to GRT.
– Develop Regulatory Position with GRT.
– Actively support regulatory compliance.
– Support the development and execution of GRT goals.

#### Win
**What we expect of you**

We are all different, yet we all use our unique contributions to serve patients. The regulatory professional we seek is a leader with these qualifications.

**Basic Qualifications:**

– Master’s degree OR
– Bachelor’s degree and 2 years of regulatory experience OR
– Associate’s degree and 6 years of regulatory experience OR
– High school diploma / GED and 8 years of regulatory experience

**Preferred Skills:**

– Master’s degree
– Strong communication skills – both oral and written
– Ability to understand and communicate scientific/clinical information
– Ability to resolve conflicts and develop a course of action
– Cultural awareness and sensitivity to achieve global results
– Planning and organizing abilities
– Able to prioritize and manage multiple activities
– Ability to deal with ambiguity
– Organizational savvy
– Negotiation skills

#### Thrive
**Some of the vast rewards of working here**

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

– Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey.
– A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act.
– Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor.

**Apply now for a career that defies imagination**

Objects in your future are closer than they appear. Join us.

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

[careers.amgen.com](https://careers.amgen.com)

### Equal Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.

Please contact us to request an accommodation.

Learn more here